TARO-WARFARIN TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

WARFARIN SODIUM

Disponible desde:

TARO PHARMACEUTICALS INC

Código ATC:

B01AA03

Designación común internacional (DCI):

WARFARIN

Dosis:

5MG

formulario farmacéutico:

TABLET

Composición:

WARFARIN SODIUM 5MG

Vía de administración:

ORAL

Unidades en paquete:

100/250/1000

tipo de receta:

Prescription

Área terapéutica:

COUMARIN DERIVATIVES

Resumen del producto:

Active ingredient group (AIG) number: 0104597001; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2000-08-09

Ficha técnica

Product Monograph
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TARO-WARFARIN
Warfarin Sodium Tablets, USP
1, 2, 2.5, 3, 4, 5, 6, 7.5, 10 mg Immediate Release Tablets
ANTICOAGULANT
Taro Pharmaceuticals Inc.
Date of Revision:
130 East Drive
November 02, 2018
Brampton, Ontario
L6T 1C1
Control No.: 221013
2
PRODUCT MONOGRAPH
Pr
TARO-WARFARIN
Warfarin Sodium Tablets, USP
1, 2, 2.5, 3, 4, 5, 6, 7.5, 10 mg Immediate Release Tablets
ANTICOAGULANT
ACTION AND CLINICAL PHARMACOLOGY
Warfarin sodium and other coumarin anticoagulants act by inhibiting
the synthesis of Vitamin K
dependent clotting factors, which include Factors II, VII, IX and X,
and the anticoagulant proteins
C and S. Half-lives of these clotting factors are as follows: Factor
II - 60 hours, VII - 4-6 hours, IX
- 24 hours, and X - 48-72 hours. The half-lives of proteins C and S
are approximately 8 hours and
30 hours, respectively. The resultant _in vivo_ effect is a sequential
depression of Factors VII, IX, X
and II. Vitamin K is an essential cofactor for the post ribosomal
synthesis of the vitamin K
dependent clotting factors. The vitamin promotes the biosynthesis of
g-carboxyglutamic acid
residues in the proteins which are essential for biological activity.
Warfarin is thought to interfere
with clotting factor synthesis by inhibition of the regeneration of
vitamin K
1
epoxide. The degree
of depression is dependent upon the dosage administered. Therapeutic
doses of warfarin decrease
the total amount of the active form of each vitamin K dependent
clotting factor made by the liver
by approximately 30% to 50%.
An anticoagulation effect generally occurs within 24 hours after drug
administration. However,
peak anticoagulant effect may be delayed 72 to 96 hours. The duration
of action of a single dose of
racemic warfarin is 2 to 5 days. The effects of warfarin may become
more pronounced as effects of
daily maintenance doses overlap. Anticoagulants have no direct effect
on an established thrombus,
nor do they reverse ischemic tissue damage. However, once a thrombus
h